Senior Director, Regulatory CMC
Senti BioCell and company
South San Francisco, United States$245,000 - $285,000Director
New Enterprise Associates
Celadon Partners
Leaps by Bayer
Nantahala Capital
The Red Hook Fund LP
Matrix Partners China
About the role
TL;DR
Senior Director, Regulatory CMC to lead global regulatory strategies for cell therapy products.
- •Lead and manage the regulatory affairs within the CMC function, developing global regulatory CMC strategies for complex cell therapy products.
- •Ensure alignment with industry standards and regulatory requirements.
- •Key Responsibilities Develop and manage CMC regulatory strategies and activities.
- •Prepare and oversee regulatory CMC submissions (INDs, BLAs, CTAs, MAAs).
- •Advise on phase-appropriate compliance for gene and cell therapy products.
- •Lead the preparation, authoring, review, and filing of CMC sections of regulatory submissions.
- •Provide strategic CMC regulatory support and guidance to cross-functional teams.
- •Requirements BA/BS in a scientific field with 10+ years of relevant experience in Regulatory affairs.
- •Strong knowledge and leadership in interpreting regulations for biologics drug development.
- •Experience in gene or cell therapy is preferred.
- •Proven ability to analyze and organize information logically.
- •In-depth understanding of industry standards and international regulations.
Domain expertise
biotechhealthcare
Benefits & perks
base salary, annual target bonus, equity